FAMCICLOVIR PENSA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Famciclovir Pensa 500 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Famciclovir Pensa and what is it used for
2. What you need to know before you take Famciclovir Pensa
3. How to take Famciclovir Pensa
4. Possible side effects
5. Storage of Famciclovir Pensa
6. Contents of the pack and further information

1. What is Famciclovir Pensa and what is it used for

Famciclovir Pensa is an antiviral medicine. It stops the infecting virus from multiplying. Since the virus reproduces in a very early stage of the infection, you will benefit more from the treatment if you start taking Famciclovir Pensa after the first symptoms appear.

Famciclovir Pensa is used to treat two types of viral infections in adults:

• Herpes zoster, a viral infection caused by a virus called varicella-zoster (the same virus that causes chickenpox). Famciclovir Pensa stops the virus from spreading in the body, so healing occurs more quickly.
• Famciclovir Pensa is also used to treat herpes zoster in the area around the eye or even in the eye itself (herpes zoster ophthalmicus).
• Genital herpes. Genital herpes is a viral infection caused by the herpes simplex virus type 1 or 2. It is usually spread by sexual contact. It causes blisters and a burning or itching sensation around the genitals, which can be painful. Famciclovir Pensa is used to treat genital herpes infections in adults. People who have frequent episodes of genital herpes can also take Famciclovir Pensa to help prevent its recurrence.

2. What you need to know before you take Famciclovir Pensa

Do not take Famciclovir Pensa

• if you are allergic (hypersensitive) to famciclovir, to any of the other ingredients of Famciclovir Pensa listed in section 6, or to penciclovir (the active metabolite of famciclovir and an ingredient in some other medicines).

If you think you may be allergic, consult your doctor.

Be careful with Famciclovir Pensa

• If you have any kidney disease (or have had it before). Your doctor may decide to give you a lower dose of Famciclovir Pensa.
• If you have problems with your immune system.
• If you have liver problems.

If any of these apply to you, consult your doctor before taking Famciclovir Pensa.

Children and adolescents (under 18 years)

Famciclovir Pensa is not recommended for use in children and adolescents.

Prevention of transmission of genital herpes to others

If you are taking Famciclovir Pensa to treat or suppress genital herpes, or if you have had genital herpes in the past, you can practice safe sex by using condoms. This is important to avoid infecting others. You should not have sex if you have pain or blisters on your genitals.

Use of Famciclovir Pensa with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

It is especially important that you inform your doctor or pharmacist if you are taking any of the following medicines:

• Raloxifene (used to prevent and treat osteoporosis).
• Probenecid (used to treat high levels of uric acid associated with gout and to increase blood levels of penicillin-type antibiotics) or other medicines that may affect your kidneys.

Taking Famciclovir Pensa with food and drinks

You can take Famciclovir Pensa with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant or think you may be pregnant, consult your doctor. Famciclovir Pensa should not be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risks of taking Famciclovir Pensa during pregnancy.

Consult your doctor if you are breastfeeding. Famciclovir Pensa should not be used during breastfeeding unless clearly necessary. Your doctor will discuss with you the potential risks of taking Famciclovir Pensa during breastfeeding.

Driving and using machines

Famciclovir Pensa may cause dizziness, drowsiness, or confusion. If you experience any of these symptoms during treatment with Famciclovir Pensa, do not drive or use machines.

3. How to take Famciclovir Pensa

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The daily dose and duration of treatment will depend on the type of viral infection you are suffering from – see below. Your doctor will prescribe the correct dose for you.
• To get the best results, start taking the medicine as soon as the first signs and symptoms appear.
• Do not have sex with anyone if you have symptoms of genital herpes – even if you have started treatment with Famciclovir Pensa. This is because you can infect your partner with the herpes infection.
• If you have or have had kidney problems, your doctor may decide to give you a lower dose of Famciclovir Pensa.

Dose for herpes zoster

If you have a normal immune system, the recommended dose is

• one 500 mg tablet, three times a day, for seven days

If you have a weakened immune system, the recommended dose is

• one 500 mg tablet, three times a day, for ten days

Dose for genital herpes:

The dose depends on the state of your immune system and the stage of your infection.

If you have a normal immune system, the dose is as follows:

For the first episode,the recommended dose is:

• one 250 mg tablet, three times a day, for five days.

For treating new episodesthe recommended dose is:

• one 125 mg tablet, twice a day, for five days.

For preventing new episodesthe recommended dose is:

• one 250 mg tablet, twice a day.

Your doctor will tell you how long you need to continue taking your tablets.

If you have a weakened immune system, the dose is as follows:

For treating the current episode,the recommended dose is:

• one 500 mg tablet, twice a day, for seven days.

For preventing new episodesthe dose is:

• one 500 mg tablet, twice a day.

Your doctor will tell you how long you need to continue taking your tablets.

If you take more Famciclovir Pensa than you should

If you have taken more tablets than you should, or if someone else has taken your medicine by mistake, go to your doctor or hospital immediately. Show them your tablet pack. You can also call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

Taking too much Famciclovir Pensa can damage your kidneys. People with kidney problems may rarely suffer from kidney failure if their dose is not lowered correctly.

If you forget to take Famciclovir Pensa

If you forget to take a dose of Famciclovir Pensa, take it as soon as you remember. Then take the next dose at the usual time. However, do not take two doses in a period of less than 1 hour, in that case skip the missed dose. Also, do not take a double dose to make up for the missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Famciclovir Pensa can cause side effects, although not everybody gets them. The side effects caused by Famciclovir Pensa are usually mild to moderate.

Severe side effects of Famciclovir Pensa:

Most of these side effects are rare or uncommon (affect between 1 and 100 out of 10,000 patients)

• Severe blisterson the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals (these could be signs of severe allergic skin reactions, see frequency below).
• Unexplained appearance of bruises, redness, or purple areas on the skin or nosebleeds(these may be signs of a decrease in the number of platelets in the blood, see frequency below).
• Swelling under the skin surface(e.g., facial swelling around the eyes, swelling of the eyelids, throat inflammation).
• Yellowing of the skin and/or eyes(signs of jaundice).

If you notice any of these side effects, contact a doctor immediately or go to the nearest emergency department.

Very common side effects (may affect more than 1 in 10 patients)

• Headache

Common side effects (may affect between 1 and 10 out of 100 patients)

• Nausea
• Vomiting
• Dizziness
• Drowsiness
• Rash
• Itching
• Abnormal liver function test results

Uncommon side effects (may affect between 1 and 10 out of 1,000 patients)

• Confusion
• Severe skin reactions

Rare side effects (may affect between 1 and 10 out of 10,000 patients)

• Hallucinations (seeing or hearing things that are not real)
• Yellowing of the skin and/or eyes
• Low platelet count

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Famciclovir Pensa

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Do not store above 30°C. Store in the original package to protect from moisture.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of deterioration.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Famciclovir Pensa

The active substance is famciclovir. Each tablet contains 500 mg of famciclovir.

The other ingredients are: Core:pregelatinized corn starch, sodium lauryl sulfate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, stearic acid. Coating:hypromellose (E464), titanium dioxide (E171), macrogol 4000, macrogol 6000.

Appearance of Famciclovir Pensa and contents of the pack

Famciclovir Pensa 500 mg is presented in the form of film-coated tablets, white, oval, scored on both sides, with approximate dimensions of 18.2 x 8.6 mm. Each pack contains 21 tablets.

The tablet can be divided into two equal halves. Use the tablets with the lowest dose concentration whenever they are available.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

PharmaPath S.A.

28is Oktovriou 1, Agia Varvara,

123 51, Greece

This leaflet was approved in December 2013

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/